FDAMarch 10, 2026device
Arjo Tenor mobile passive patient lift, Model Numbers KHA1000 US and KHA1010 US
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
An internal component of the actuators in a certain production batch may not meet the required mechanical strength. This could result, in the worst case scenario, in a sudden loss of the actuator's ability to hold the load, leading to rapid and uncontrolled downward movement of the lifting arm.
What to do
FDA enforcement status: Ongoing
Brands named
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UPCs
0505598278775805055982787710
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAArjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive Assistance module and retrofitted with IndiGo Drive Assistance modules2023-08-29
- FDAArjo medical beds, Models Enterprise 5000X, Enterprise 8000X, Enterprise 9000X and Citadel, assembled with IndiGo Drive Assistance module and retrofitted with IndiGo Drive Assistance modules2023-08-29
- FDAArjo Portable Scale Adaptor, Model Number 700.05725; accessory intended to be used in combination with compatible patient lifting equipment2023-02-17
- FDASara Plus Active Floor Lift2022-04-05
- FDAArjo Citadel beds originally assembled with the IndiGo modules during manufcturing, model number CX812A3J3AMAD0; and IndiGo modules (retrofit kits) that can be installed on Citadel (model no. INDIDAA) or Enterprise (model no. INDIJAA) beds manufactured without IndiGo modules assembled at the time...2021-06-10
- FDAMaxi Sky 1000 (Arjo) and V10 (BHM) Bariatric Ceiling Rail - Mounted Lift with measuring function2021-03-04
- FDAArjo Flat Dynamic Positioning System (DPS) - Product Usage: used in conjunction with passive clip slings is designed for resident transfer in a homecare setting, at nursing homes and other assisted living centers. Please note that the DPS can be utilized only if affixed to ceiling lift or passive...2020-10-06
- FDABariatric Bed Frame System The Citadel Plus Bariatric Bed Frame System is intended for the acute and post-acute care environments. It is not intended for use in the home care environment.2020-07-21
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